YAZ and Yasmin Birth Control Medication Lawsuits

Birth Control Medication Lawsuits (Yaz, Yasmin, and Ocella Birth Control Drug Lawsuits)

YAZ, Ocella, and Yasmin are oral contraceptives that produced over $1 Billion in sales in the United States and $1.8 Billion worldwide in 2008. These birth control pills are oral contraceptives that have been heavily marketed by Bayer HealthCare Pharmaceuticals, Inc., however, the FDA has found that past marketing campaigns were misleading as it minimized the potential health risks that have been associated with these oral contraceptives. These health risks include sudden death, cardiovascular problems, blood clots, heart attacks, stokes, and gallbladder disease.

Yaz, Yasmin, and Ocella Birth Control Medications Contain Drospirenone (DRSP) that has been Associated with Serious Health Risks

YAZ and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). These birth control medications are manufactured by Bayer HealthCare Pharmaceuticals, Inc., while Ocella is the generic equivalent of Yasmin that is manufactured by Barr Laboratories. Each of these birth control medications contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP). Drospirenone is known for increasing the risk for hyperkalemia and these DRSP oral contraceptives have been associated with adverse health effects such as Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

YAZ Marketing Campaign Created Annual Revenues of over $600 Million, but Overstated Drug Benefits and Understated Drug Dangers

The FDA has found that Bayer's marketing campaign that was directed at young women for the birth control drug, YAZ, was misleading. The misleading marketing campaign allowed YAZ to become the best-selling oral contraception pill in the United States with annual sales revenue of over $600 million in 2008, but understated the birth control medications' health risks.

Through the efforts of the FDA and several states' Attorney Generals, the manufacturer and marketer of the oral contraceptive YAZ was required to run a $20 million advertising campaign for the purpose of correcting previous YAZ marketing statements and will be required to submit all future YAZ ads for the next six (6) years to the FDA for screening.

The YAZ ads allegedly overstated the pill's ability to improve women’s moods and clear up acne, while not fully warning of the drug's potential serious side effect health risks including Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

Recent FDA and Attorney Generals Take Action to Correct the YAZ Marketing Campaign Making Sure Bayer Does Not Understate Drug Dangers and Risks

In October 2008, the FDA took action against Bayer sending a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. The FDA warning letter stated that two 60 second direct to consumer broadcast television advertisements entitled "Not Gonna Take it" and "Balloons" submitted by Bayer HealthCare Pharmaceuticals, Inc. were "misleading because they broaden the drug's indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug". Further, that these televisions advertisements "misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act".

The FDA had approved YAZ as a birth control pill that has a side benefit in treating a very specific mood-related psychological problem called "premenstrual dysphoric disorder" and improving moderate acne, however, Bayer overstated the drug's efficacy and minimized its potential dangers.

FDA Action against Yasmin for Minimizing Health Risks in 2003 Suggests Bayer May Have Had Prior Knowledge of Misleading Marketing that Minimized YAZ Health Risks

The contraceptive medication, YAZ, closely resembles another birth control medication, Yasmin. Both drugs contain contain ethinyl estradiol and the "fourth generation" progestin drospirenone (DRSP). Yasmin has been the subject of a similar FDA warning letter in 2003 that warned the manufacturer and marketer that their marketing advertisements were understating potential health risks and overstating the benefits of the birth control medication. At that time Yasmin was manufactured and marketed by Berlex Laboratories.

In 2006, Bayer HealthCare Pharmaceuticals, Inc. acquired Berlex Laboratories. Bayer now markets both oral contraceptives, YAZ and Yasmin which had sales of about $1.8 Billion in 2008.

Health Risks Related to the Oral Birth Control Mediations
Yaz, Yasmin, and Ocella

YAZ, Yasmin, and Ocella contain drospirenone (DRSP), a synthetic progestational compound that can cause serious side effects and has been associated with serious health problems including formation of dangerous blood clots, strokes, pulmonary embolisms (PE), gallbladder disease, deep vein thrombosis (DVT), heart attacks, and sudden death. Yaz and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). Both have been linked to blood clots and cardiovascular events as well as other serious health risks.

While it has long been known that taking a combined oral contraceptive (COC) pill with a combination of estrogen and a progestin hormone can increase the risk of stroke and blood clots in the legs and lungs, the health risks of newer synthetic should have been deceptively marketed as having less health risks with other benefits that the contraceptives do not have.

In October 2008, the Food and Drug Administration (FDA), concerned with the improper advertising of the YAZ/Yasmin/Ocella birth control drugs, issued a warning letter to the Bayer Corporation to cease unlawful promotion. Also, women who have taken these popular oral contraceptives reported serious side effects, including blood clots, stroke, gallbladder complications and heart attack as a result of taking the drugs.

It is thought that these birth control medications contain hormones the effect cholesterol metabolism and excretion into the gallbladder thereby affecting the cholesterol concentration and crystallization of bile acids in the secretions leading to gall stones as well as can lead to clots, strokes, or heart attacks.

For more information on YAZ/Yasmin/Ocella birth control drug Lawsuits, please go to the following YAZ Yasmin Ocella Lawsuit Website.

Medicaid and Medicare Upcoding & Fraud Whistleblower Lawsuits

Medicaid and Medicare Upcoding and Fraud Whistleblower Lawsuits (Upcoding Qui Tam Claims, Mischarging for Services Claims, Double Billing Qui Tam Claims, Illegal Kickback Qui Tam Claims, & Other Medical Service Provider Fraud Claims)

Healthcare fraud costs taxpayers an estimated $100 billion each year. Illegal Kickbacks, Upcoding, Double Billing, False Coding, and fraudulent mischarging of health care services are just a few ways that fraudulent medical providers are able to defraud Medicare, Tricare, the Veterans' Administration (VA), and other government services out of billions of dollars. Heroes including health care administrators, doctors, nurses, and therapists are stepping forward and blowing the whistle on Tricare, the Veterans' Administration (VA), and Medicare billing fraud including manipulation of outlier payments to Medicare, kickbacks, upcoding, or bill padding. If you are a healthcare professional that is aware of fraud, please become a Tricare, Veterans' Administration (VA), Medicaid, or Medicare Whistleblower.

Health Care Fraud Upcoding Whistleblower Law Suits (Medicare, VA, and Tricare Upcoding Qui Tam Whistleblower Claims)

Upcoding occurs when a medical service provider intentionally and fraudulently upcodes services to obtain a higher reimbursement than one that is entitled to for the service that was actually provided. In both the Medicare and Medicaid systems a set of billing codes is used by healthcare providers to bill for services. These codes are known as the Healthcare Common Procedure Coding System (HCPCS). A service provider that intentionally uses a higher paying code to fraudulently reflect that a more expensive procedure or device was involved in the patient’s treatment than actually was used or was necessary. A pattern of intentional upcoding treatment can result in large profits for the healthcare provider, but also cost taxpayers millions of dollars.

Upcoding fraud is typically hard to catch without the help of persons with inside information because that Healthcare Common Procedure Coding System (HCPCS) codes are billed electronically and can easily slip through the system. Therefore unless the upcoding is caught through a random audit (approximately 2% of the claims per year are audited), it is up to insiders, informants, heroes, and health care professionals to catch fraudulent upcoding.

Another type of coding fraud is “unbundling”, where bundled related procedures or composite lab tests are run together, but billed separately by the lab or healthcare provider to obtain more compensation. These types of billing fraud also allow healthcare providers and labs to make higher profits by bilking Medicare, Medicaid, and taxpayers out of millions of dollars. These unbundling fraud schemes are also hard to detect without someone that is familiar with the codes and billing.

Qui Tam Whistleblower Plaintiffs have received over $1 Billion in Awards of the over $12 Billion in Recoveries for Exposing Fraud Against the United States Government (Qui Tam Plaintiff Whistleblower Claims)

Medicaid, Tricare, Veterans Administration, Hospice, and Medicare Whistleblowers that provide original source information of schemes to fraudulently take money from our United States government including upcoding, double billing, bill padding, unbundling, and charging for services never provided may recover a portion of the proceeds recovered on the government's behalf. Since 1986, relators have recovered over $1 billion for helping expose fraud against the United States government.

Below is an excerpt from the False Claims Act explaining what types of awards qui tam whistleblowers may recover for being the "original source" of information that is used to successfully expose fraud against Medicaid, Tricare, Veterans Administration, Hospice, Medicare, or another subdivision of the United States Government and recover money from the parties committing the fraud.

(d) AWARD TO QUI TAM PLAINTIFF

(1) If the Government proceeds with an action brought by a person under subsection (b), such person shall, subject to the second sentence of this paragraph, receive at least 15 percent but not more than 25 percent of the proceeds of the action or settlement of the claim, depending upon the extent to which the person substantially contributed to the prosecution of the action. Where the action is one which the court finds to be based primarily on disclosures of specific information (other than information provided by the person bringing the action) relating to allegations or transactions in a criminal, civil, or administrative hearing, in a congressional, administrative, or Government [General] Accounting Office report, hearing, audit, or investigation, or from the news media, the court may award such sums as it considers appropriate, but in no case more than 10 percent of the proceeds, taking into account the significance of the information and the role of the person bringing the action in advancing the case to litigation. Any payment to a person under the first or second sentence of this paragraph shall be made from the proceeds. Any such person shall also receive an amount for reasonable expenses which the court finds to have been necessarily incurred, plus reasonable attorneys’ fees and costs. All such expenses, fees, and costs shall be awarded against the defendant.

(2) If the Government does not proceed with an action under this section, the person bringing the action or settling the claim shall receive an amount which the court decides is reasonable for collecting the civil penalty and damages. The amount shall be not less than 25 percent and not more than 30 percent of the proceeds of the action or settlement and shall be paid out of such proceeds. Such person shall also receive an amount for reasonable expenses which the court finds to have been necessarily incurred, plus reasonable attorneys’ fees and costs. All such expenses, fees, and costs shall be awarded against the defendant.

Since amendments were made to the Federal False Claims Act in 1986, citizens that have filed suits on behalf of the federal government against government contractors that have participated in defrauding the government have regained over $12 Billion for taxpayers as well as have collected over $1 Billion in qui tam whistleblower awards.

Government Contractor Fraud Qui Tam Whistleblower Lawsuit Information (False Claims Act Whistleblower Qui Tam Action Information)

For more information on Medicare Fraud, Tricare Fraud, Medicaid Fraud, Defense Contractor Fraud, Off Label Fraud, Road Construction Fraud, and other types of False Claims Act Whistleblower Claims, please go to the Qui Tam, Whistleblower, and Federal Federal False Claims Act Information Center or the following webpage on Medicaid and Medicare Upcoding & Fraud Whistleblower Lawsuits (Upcoding Qui Tam Claims, Mischarging for Services Claims, Double Billing Qui Tam Claims, Illegal Kickback Qui Tam Claims, & Other Medical Service Provider Fraud Claims) .

Texas Birth Injury, Small Child Injury, and Birth Defect Lawsuits

Texas Birth Injury Lawsuits, Texas Primary Pulmonary Hypertension PPH Lawsuits, Texas Infant Traumatic Injury Lawsuits, and Texas Small Child Traumatic Injury Lawsuits (Birth Injury and Birth Defect Lawsuits)

Avoidable birth injuries, birth defects, fatal accidents, and traumatic injuries are some of the most devastating problems that can occur to a parent, family, and/or a small child. Parents and family who should be celebrating the life of their new child, are often caught off guard when their child is taken from them, born with severe disabilities, or suffers significant injuries in an avoidable accident. After a death, accident, or discovery of a birth defect, the family is often busy taking care of the child with the serious health problems or grieving their loss, and often does not have the time or energy to seek compensation from or battle the party or parties that caused the death, birth defect or accident.

Texas Birth Injury Hypoxia Brain Damage Lawsuits
(Causes of Hypoxia During Birth)

Several types of accidents and negligent actions can cause an unborn child to suffer hypoxia resulting in a brain injury during the birthing process including a difficult labor, unreasonable delay in performing a C-section, delay in delivering an extremely large baby, gestational diabetes in the mother, failure to properly and timely resuscitate the baby, maternal or fetal bleeding complications, excessive administration of Pitocin, and placenta previa. It is important during any birth to have medical professionals that are able to protect the safety of the mother and child by not allowing any of these factors to become a problem. If problems arise and these difficulties occur during the birth of your child and the child sustains a brain injury, you may want to contact a Texas Birth Injury Lawyer with the skill and dedication to help you get the compensation.

Texas Medication Birth Defect Lawsuits

Several medications, products, and drugs have been linked to birth defects. Some of these medication and products have ample warnings that warn pregnant women to avoid taking these products while they are pregnant, however, some manufacturers have hidden the real dangers of their product in order to sell more of their product and value profits over healthy babies. For these manufacturers, they may have short term profits, but over the long term they will suffer for the long term birth defects that they have caused.

Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs)
Birth Defect Claims and PPH and PPHN Lawsuits

Some medications that have been linked to birth defects include Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs). Women that have taken SSRIs after the 20th week of pregnancy have a 6-fold increased risk of their child developing persistent pulmonary hypertension, a life-threatening lung disorder. Infants with persistent pulmonary hypertension have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies and may become very sick or die. The SSRIs antidepressants that have been linked to persistent pulmonary hypertension (PPHN) include Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

Infants born with PPHN often require mechanical assistance to breath and even worse about 10% to 20% of the infants do not survive even when they receive treatment. The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.

Lamictal Birth Defect Claims

Lamictal is a drug used to treat bipolar episodes and the most serious forms of epileptic seizures. Unfortunately, there is now an association between pregnant women taking Lamictal in there first three months of pregnancy and their children being born with a cleft palate or lip.

Cerebral Palsy Medical Negligence Lawsuits, Texas Medical Negligence Lawsuits, and Federal Tort Claims Act Negligence Lawsuits

"Cerebral" refers to the brain and "palsy" to muscle weakness/poor control. Cerebral palsy itself is not progressive, but is a developmental problem that can occur during fetal development, the birthing process, or infancy. Once a child has cerebral palsy, the child will not get worse over time, however, conditions such as muscle spasticity can develop which may get better or worse over time. Although cerebral palsy is not "curable", training and therapy treatments can help improve function.

The term "cerebral palsy" refers to any one of a number of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. Even though cerebral palsy affects muscle movement, it isn’t caused by problems in the muscles or nerves. It is caused by abnormalities or damage in parts of the brain that control muscle movements. The majority of children with cerebral palsy are born with it, although it may not be detected until months or years later. The early signs of cerebral palsy usually appear before a child reaches 3 years of age. The most common symptoms are a lack of muscle coordination when performing voluntary movements (ataxia); stiff or tight muscles and exaggerated reflexes (spasticity); walking with one foot or leg dragging; walking on the toes, a crouched gait, or a “scissored” gait; and muscle tone that is either too stiff or too floppy. A small number of children have cerebral palsy as the result of brain damage in the first few months or years of life, brain infections such as bacterial meningitis or viral encephalitis, or head injury from a motor vehicle accident, a fall, or child abuse.

Cerebral Palsy usually occurs during fetal development, but can occur before, during, or shortly after birth; or during infancy. The faulty development or damage to motor areas in the brain disrupts the brain's ability to adequately control movement and posture. Symptoms of Cerebral Palsy can range in severity. Medical mistakes during the labor and delivery process are to blame for thousands of children with Cerebral Palsy. Unfortunately, many parents don't realize that their healthcare provider might be to blame for their child's Cerebral Palsy.

Causes of Serious Brain Injuries and Brain Damage (Traumatic Brain Damage Lawsuits)

Serious brain injuries can occur through traumatic impact to the head caused by an automobile accident, serious fall, falling object, construction accident, accidental gun shot, boating accident, or a vicious attack. Severe trauma to the head can cause the brain to move inside the skull and injure the brain. The skull typically protects the brain from injury, but because the inside of the skull is rough a traumatic event that causes the brain to move or to swell inside the skull can cause the brain to press up against the skull and cause serious brain damage.

Texas Infant Brain Injury, Child Head Injury, and Hypoxia (Medication Interaction, Carbon Monoxide, and Drowning Victim) Lawyer

Brain injuries including Hypoxia can be caused by several factors including a traumatic injury, lack of oxygen, drowning, carbon monoxide poisoning, smoke inhalation, or drug interactions. If you or a loved one have suffered a serious brain injury or brain damage, the most important thing you can do is to find a good medical doctor to assess the injury so you know what you are dealing with and how to best treat the injury.

Federal Tort Medical Malpractice Claims Act, Product Liability, Traumatic Injury, and Texas Medical Negligence Birth Defect Lawsuits

Federal Tort Claims Act Medical Negligence Lawsuits, SSRI Antidepressant PPH Product Liability Lawsuits, Texas Traumatic Injury to an Infant, and Texas Medical Malpractice Birth Defect Lawsuits are some of the most complicated types of cases in the practice of law. For more information on these types of cases, please go to the following webpage on Texas Birth Injury, Texas Small Child Injury Lawsuits, and Texas Birth Defect Lawsuits.